Pressurized portable dispenser

ABSTRACT

A portable powder dispensing device has a medicament chamber in which a dose of powdered medicament in an open capsule shell is introduced and an outlet to cooperate with a human body cavity, such as a mouthpiece or a nozzle for inserting in a nostril. A jet of gas under pressure, from a propellant tank is introduced into the chamber at a swirl angle. The shell containing the medicament vibrates and spins thereby breaking up the particles or aggregates.

United States Patent 1191 Hansen 1111; 3,809,084 1 May 7, 1974 1PRESSURIZED PORTABLE DISPENSER [75] Inventor: Lloyd Frank Hansen,Campbell Hall, N.Y.

[73] Assignee: American Cyanamid Company,

Stamford, Conn.

[22] Filed: Feb. 8, 1972 [21] Appl. No.: 224,497

Related US. Application Data [63] Continuation-impart of Ser. No.11,555, Feb. 16,

1970, Pat. No. 3,653,380.

[52] US. Cl 128/266, 128/187, 222/190,

1 1 239/315 [51] Int. Cl. A611 13/00, A6lm 15/08 [58] Field of Search128/172, 173, 185, 186,

[56] References Cited UNITED STATES PATENTS 7 2,533,065 12/1950 Taplinet a1 128/266 X 2,722,935 11/1955 Thompson et a1. 128/266 Ramis ..L128/203 x 3,184,115 5/1965 Meshberg 128/173 R 3,357,427 12/1967 Wittkeet a1. 128/260 X 2,642,063 6/1953 Brown 128/206 3,355,071 11/1967 Jordan222/190 2,517,482 8/1950 Hall 128/206 2,992,645 7/1961 Fow1er.....128/266 X 2,865,370 12/1958 Gattone 128/173 R Primary Examiner-RichardA. Gaudet Assistant Examiner-J. C. McGowan Attorney, Agent, orFirmSamuel Branch Walker [57] 7 ABSTRACT A portable powder dispensingdevice has a medicament chamber in which a dose of powdered medicamentin anopen capsule shell is introduced and an outlet to cooperate with ahuman body cavity, such as a mouthpiece or, a nozzle for inserting in anostril. A jet of gas under pressure, from a propellant tank isintroduced into the chamber at a swirl angle, The shell 1 containing themedicament vibrates and spins thereby breaking up the particlesoraggregates.

1 Claim, 7 Drawing Figures PATENTEDW H914 sum .1 0r 2 ATENTEDHAY 1 m43.809.084

SHEET 2 OF 2 fIE-5 1 PRESSURIZED PORTABLE DISPENSER CROSS REFERENCESThis application is a continuation-in-part of copending application Ser.No. 11,555, filed Feb. 16, 1970, now.U.S. Pat. No. 3,653,380, dated Apr.4, 1972. The references in the prosecution thereof are herebyincorporated by this reference thereto.

BACKGROUND OF THE INVENTION A number of medicaments are introducedeither orally or nasally. For instance, there are a number of nasalinhalators and there are also some devices for introducing finelydivided medicament into the oral cavity and thence on into therespiratory system. In the past there were two general types. The nasalinhalator had a medicament chamber, openings to the atmosphere, and anozzle which was introduced into the nostril. On inhaling, air wassucked into the chamber, picked up medicament, and was inhaled by theuser. The dispensers for the oral cavity not only had a different shapedmouthpiece but often had a container feeding into a venturi tube throughwhich air or a gas flowed, picking up the medicament. Some used asqueeze bulb or compressed air source to suspend the powder. I

Wherethere was no reason to measure the dose accurately, these types ofdispensers were quite satisfactory and are used on a large scale,particularly the nasal inhalators. It was difficult or impossible tointroduce a definitely measured dose, with most of these devices.

It is with improved dispensing devices which can dispense' accuratelymeasured doses that the present invention deals.

SUMMARY or THE iNvENTioN The present invention departs from priordesigns in several important respects. First, there is a medicamentchamber into which gas or air under pressure is introduced at a swirlangle to create turbulence so that the entire dose in the chamber iscarried oninto the body cavity, e.g., nose or mouth, and thence into therespiratory system, or vagina, ear or wound for local therapy. Animportant feature is a loose element in the medicament chamber such ashalf of the shell of a capsule carrying a dose of medicament. This shellspins, vibrates and collides with the powdered medicament thuspreventing the formation of or breaking up any coarser aggregates.Adhering of medicament to the'walls of the dispensing chamber is greatlyreduced and for the most part completely eliminated, and moreimportantly is consistent for any given system.

The present invention permits discharging finely divided solid particlesfrom an accurately predetermined dosage either into the nose or mouth orsimilar body cavity. No problem of over dosage is presented, which was aproblem with some dispensers used in the past. With medicaments which inexcessive amounts have undesirable effects, complete safety is assured.

In one form, the dispenser of the present invention at first glanceappears somewhat similar to a nasal inhalator. However, the air passagesare scaled up and a gas duct carries gas under pressure into a side ofthe mixing chamber. As the gas comes in at an angle, called the swirlangle, there is high turbulence and a very thorough distribution of themedicament results. A measured dose of medicament is ordinarilyintroduced in a half of a capsule. The capsule half vibrates violently,which results in complete emptying of medicament dose and also breaks upaggregates, giving a fine aerosol or smoke, defined as a suspension ofsolid particles in gas.

I Ordinarily the gas duct enters the medicamentchamher at an angle whichis not a right angle. The particular angle is not critical so long as itis a sufficient angle to produce a high degree of turbulence. A liquidmay be introduced in the capsule half shell, if the medicament ismore'readily administered in liquid form. The most important use for thepresent invention is to introduce a medicament into the respiratorysystem, but it is possible to introduce small doses of medicament intothe nasal passages without their being driven into the lungs. Also,while the nose and mouth are the cavities in which the dispensers of thepresent invention are primarily used, other bodily cavities can alsoreceive accuratelypredetermined dosages of finely divided medicament;and therefore, in its broader aspects the present invention is notstrictly limited to dispensers to be used in oral or nasal use. v

The source of the gas under pressure is not a critical part of thepresent invention. It is convenient to form the gas introducing tube forthe mixing chamber so that it can be pressed on the discharge valve ofan ordinary aerosol container or pressure tank which contains a volatileliquid or gas, such as Freon, of suitable boiling point.

,Chlorofluoroalkanes and mixtures of them give propellants withpreferred pressure characteristics. Di-

chlorodifluoromethane, sold under trademarks such as Freon 12 orGenetron i2, is conveniently commercially obtainable in small pressuretanks having a depressable stem valve. Such pressure tanks areused aspower units for spray paints, noise devices, signal ing systems, andmany other purposes.

Inthe quantities used for powder dispensing, dichlorodifluoromethane isessentially non-toxic. In larger quantities, it dilutes the oxygenin theair to such an extent that it can become suffocating. Other propellantssuch as carbon dioxide in cylinders, or compressed air or compressedoxygen from tanks or a supply line may be used as a power source. Wherefixed compressed gases such as oxygen or air are used as a power source,

the complexity of pressure reducing devices to give a uniform pressurefor the dispensing of the medicament introduces a cost and weight thatis unacceptable for some usages. For use in a doctors office or underhospital conditions where a large number of doses are to be dispensedand skilled maintenance is available and weight is not critical, suchcompressed gas, particularly oxygen, is quite advantageous as the oxygencan aid breathing performance and is frequently used in respiratorytherapy to reduce the load on the heart and lungs, and is readilyavailable.

The use of dichlorodifiuoroniethane or other of the haloalkanes permitsa very compact and readily portable package and may be considered as thepreferred form of use of the invention. It should be understood thatwhen the dispenser is pressed onto the discharge valve of a pressuretank it should be pressed for a short but sufficient time to assure thatthe full dosage of medicament in the dispensing chamber is ejected intothe desired body cavity. This presents no problem as an exact timemeasurement is not needed.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-section through anasal inhalator of the present invention.

FIG. 2 is a cross-section through a nasal inhaler which fits axially onthe pressure tank and discharges powder at an angle. I

FIG. 3 is a cross-section on line 3-3 of FIG. 2 showing a cross-sectionof the dispenser, particularly the swirl angle of the gas duct.

FIG. 4 is a modification of the dispenser showing radial pressurizationand axial discharge with threaded assembly.

FIG. 5 is a drawing on a smaller scale showing the use of a dilutionchamber for the dispersed aerosol.

FIG. 6 is a cross-section of a simplified two-piece assembly in whichthe propellant tank feeds directly into the medicament chamber.

FIG. 7 is a cross-section along lines 77 of FIG. 6.

DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 shows a powder dispenser inwhich a gas duct 13, which at its other end attaches to the valve of theaerosol can or propellant tank 14 enters at a swirl angle into themedicament chamber 12 in the dispenser housing 11. In use, the nasalnozzle 15 is removed by unscrewing at the threaded nozzle coupling 16and half of a hard shell capsule 17 containing a powdered medicament 18is introduced into the medicament chamber 12. The nasal nozzle 15 isthen fastened on by screwing or by friction fit and the gas duct 13 isbrought into contact with the valve stem 19 of an aerosol can orpropellant tank 14. Theblast of Freon enters at a swirl angle, causeshigh turbulence in the medicament chamber 12 which is further enhancedby the vibration and spinning of the half capsule 17, resulting incomplete emptying thereof and in further turbulence, so that the wholedose of powdered medicament 18 is introducedthrough the nasal nozzle 15into the nostril of the user.

The medicament to be dispensed may be any of the therapeutic agentswhich are desirably administered in finely divided powdered form. Whilenot restricted to such powder size, materials having a particle size of90 percent smaller than 5 microns are conveniently administered by thepresent type of portable powder dispenser. Larger powders may beadministered, but usually less elegant techniques are satisfactory withthe larger powders. Among the finely powdered medicaments are penicillinor salts or derivatives thereof, steroids or a therapeutically effectivesalt or derivative thereof, and isoproternol as well as live virusmaterials. Some such live viruses materials are disclosed in US. Pat.No. 2,798,835, Markham and Cox, NEWCASTLE DISEASE AND INFECTIOUSBRONCHITIS VAC- CINES AND PRODUCTION THEREOF, and US.

live virus products may be administered to humans or other mammals. Thepresent type of dispenser is particularly advantageous with medicamentswhich are sensitive to moisture or storage conditions. The medicamentmay be stored under conditions most advantageous for storage, and yetreadily transferred to the present dission on administration.

An axial-feed, angular-dispensing modification of the invention is shownin FIG. 2. Here the dispenser housing 21 is a massive plastic block inwhich is formed the medicament chamber 22. A gas duct 23 is formed inthe dispenser housing, conveniently by drilling, so that one wall isnearly tangent to the medicament chamber, as shown in FIG. 3. This givesa highly effective swirl angle so that 'as the dispersing propellant isintroduced into the medicament chamber a high degree of spin andturbulence is attained. The nasal nozzle 25 is a press fit into themedicament chamber and has a discharge duct 26 leading axially from themedicament chamber, with a bend of approximately 45, so that the finelydivided powder being dispersed is dispensed at a convenient angle fororal or nasal administration. Half of a hard shell capsule 27 containinga powdered medicament 28 fits into the medicament chamber 22 to bedispersed at time of use.

One configuration which gives excellent results for powdered steroids isfor the inner chamber to beabout 0.28 inches in diameter and about 0.5inch depth with a radius at the bottom of the chamber. The largerportion of a number 5 hard shell capsule which is approximately 0.38inches long and approximately 0.19 inches in diameter fits loosely intothe medicament chamber. With this size, the half of a hard shell capsulecannot turn over but is maintained in a somewhat upright position whereit can rotate and vibrate but not turn over. If the chamber diameter istoo small, the half capsule shell forming the medicament container willnot rotate and vibrate and if it is too large, the capsule shell canbecome tilted and jammed and hence prevent rotation. The gas pressurethrough the gas duct should be such that the half capsule shell has ahigh rotational velocity, but not so high as to fracture. If too muchpressure is fed in, the half capsule shell itself may be disintegrated.Stroboscopic observation shows that a rotational and vibrational rate ofabout 1,200 to 2,000 cycles per minute gives excellent results. For suchrotational speeds the rotation and vibration dislodges the finelydivided powder from the capsule shell, causing the powder to be pickedup by the moving gas, and the entire suspension, now known as an aerosolor smoke, is discharged through the discharge duct for administration,such as inhalation by the subject.

While shown as a nasal nozzle, the orifice can be adapted to suit thesite of application, for instance the mouth, the ear, the vagina, or asurface to which th powder is to be applied.

The dispenser housing is shown as fittin'g tightly into an outerdispenser holder 29. The space between the outer dispenser holder 29 andthe-dispenser housing 21 acts as a damping chamber 30 which smooths outany vibrations or variations in the propellant flow, aids in preventingliquid portions of the propellant being fed into themedicament chamber,and enhances smooth operation. A pressure chamber adapter 31 has a sizeand shape to fit over the stem 32 of a discharge valve on a propellanttank 24. Conveniently the pressure chamber adapter has a size such thatfrom about 10 to about 15 cubic feet per minute of propellant gas flowinto the damping chamber. The size of the pressure chamber adapter iscritical to the extent that it must fit smoothly over the stem of thedispensing valve on the propellant tank without excess gas leakage butother than mating to each other, there are no critical limitations onsuch dimensions. Preferably the pressure chamber adapter fits currentcommercial valve stem standards.

In FIG. 4 is shown a modification in which the dispenser housing 34 hasfemale threads 35 to receive male threads 36 on the end of an axialnasal nozzle 37. In this configuration, there is less chance of thenasal nozzle being blown out of the medicament chamber 38. The dispenserhousing 34 is also adapted to be retained by screw threads 39 in theouter dispenser holder 40. A pressure adapter 41 fits over the stem 42of the valve on a propellant tank 43. Here the propellant tank and stemare radial, and hence adaptedto be held vertically while the nasalnozzle 37 is held horizontal to dispense a medicament into the mouth,ear or nose of a user. Because of the nature of the device, the completeassembly may be held in any angle which is convenient foradministration. Some valves on, the propellant tank operate moreeffectively if held above the surface of any propellant in the tankwhich may be in liquid form, but other valves work satisfactorily whenheld in any position.

A modification of the axial flow device in FIG. 4 is shown in FIG. 5 inwhich a shoulder 45 is formed on the dispenser housing 34 to cooperatewith a dilution chamber 46. The dilution chamber is a hollow cylinder,

conveniently with a housing coupling 47 which fits over and against theshoulder 45 to hold the dilution chamher in position. Vents 48 permitthe flow of air into the dilution chamber. The discharge end of thedilution chamber has a mouthpiece 49 which can fitinto the mouth of theuser. A dust cap 50 may be removably placed over the mouthpiece to keepit clean when not in use.

In use, the dilution chamber permits the aerosol or smoke as it isemitted from the nozzle to be diluted with air, and aggregates orunground particles to settleout or fall against the wall of the dilutionchamber, so that a more uniform, more dilute aerosol is served to theuser whereby a deeper therapy is readily obtained by inhaling the smokeor aerosol deeper into the lungs. Such a dilution chamber also aids inmaintaining a uniform dosage. Part of the dose in the capsule shell islost in the dilution chamber but as the portion lost is consistent, amore consistent dosage may be administered to the user. A small butconsistent loss to give a more uniform dosage is advantageous with thosemedicaments for which the dosage level is critical.

A simplified modification is shown in FIGS. 6 and 7 in which thedispenser housing 52 is a single rectangular block having a medicamentchamber 53 formed therein with screw threads to hold the nasal nozzle54. The nasal nozzle is axial with the medicament chamber andconveniently formed on automatic screw machines. At right angles anoffset is the pressure chamber adapter 55 which fits over the stem of apropellant tank, not shown, and which feeds the pressurizing gasdirectly into the medicament chamber where the gas spins the half hardshell capsule 56 containing the medicament 57. This configuration may besmaller and lighter than those above shown and is thus adapted to becarried in the pocket of a user.

.The assembly of a small pressure tank, the dispenser housing, the nasalnozzle and a supply of capsules containing medicaments may be put in asmall case which fits into the pocket of and is carried by the user. Forsuch uses, it is convenient to have the other half of the hard shellcapsule emplaced over the half containing the medicament so that acomplete hard shell capsule is carried by the user and opened justpriorto administration. The top can be removed from the hard shellcapsule, the half containing the medicament dropped into the medicamentchamber, and the nasal nozzle screwed into retaining location, the stemof the pressure tank placed in the pressure chamber adapter, and a dosedispensed to the user with a minimum of time if the patient is subjectto distress symptoms such that rapidity of administration becomescritical.

Other modifications of the present powder dispenser are within the scopeof the invention which is defined by the following claims:

I claim:

l. A dispenser system for introducing a finely powdered medicament intoa body opening, comprising, in combination:

a dispenser housing having therein a medicament chamber, and removablyattached thereto,

a nozzle having one end shaped to cooperate with a body cavity, and theother end attached to said dispenser housing and closing the medicamentchamber, and having a central discharge duct therethrough from endtoend, M

said medicament chamber being adapted to hold a movable solid medicamentcontainer having therein a single powdered medicament dose whichcontainer vibrates and spins when gas under pres sure is introduced intosaid chamber thereby increasing the inherent swirl and turbulence due tothe introduction of gas under pressure,

in said medicament chamber a medicament container about the size andshape of half of a hard shell capsule, adapted to move freely in but notturn over in said medicament chamber, and a predetermined single dose ofa powdered medicament in said container,

at least one gas duct passing through the wall of said dispenser housingand entering nearly tangent to the medicament chamber for introducinggas under pressure into the medicament chamber at a swirl angle to thechamber, whereby turbulence results,

means to introduce gas under pressure through said gas duct, wherebysaid powdered medicament in said container is efficiently dispersed inthe turbulent gas and essentially completelyadministered at duct intothe medicament chamber.

1. A dispenser system for introducing a finely powdered medicament intoa body opening, comprising, in combination: a dispenser housing havingtherein a medicament chamber, and removably attached thereto, a nozzlehaving one end shaped to cooperate with a body cavity, and the other endattached to said dispenser housing and closing the medicament chamber,and having a central discharge duct therethrough from end to end, saidmedicament chamber being adapted to hold a movable solid medicamentcontainer having therein a single powdered medicament dose whichcontainer vibrates and spins when gas under pressure is introduced intosaid chamber thereby increasing the inherent swirl and turbulence due tothe introduction of gas under pressure, in said medicament chamber amedicament container about the size and shape of half of a hard shellcapsule, adapted to move freely in but not turn oVer in said medicamentchamber, and a predetermined single dose of a powdered medicament insaid container, at least one gas duct passing through the wall of saiddispenser housing and entering nearly tangent to the medicament chamberfor introducing gas under pressure into the medicament chamber at aswirl angle to the chamber, whereby turbulence results, means tointroduce gas under pressure through said gas duct, whereby saidpowdered medicament in said container is efficiently dispersed in theturbulent gas and essentially completely administered at a single timeof use, into the body cavity, said means including an outer dispenserholder attached to said dispenser housing surrounding said gas duct andspaced from a portion of said dispenser housing forming a dampingchamber between said outer dispenser holder and the dispenser housing,and a pressure chamber adapter passing through said outer dispenserholder to receive the stem of a dispensing compressed gas propellanttank, thereby permitting pressurization of the damping chamber, and thedamped transfer of gas pressure through the gas duct into the medicamentchamber.